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Stereotactic Volumetric Radiotherapy in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Hypofractionated radiotherapy, SBRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histology of prostate adenocarcinoma
  • Age≥ 18 years
  • Life expectancy≥ 10 years
  • Clinical negative nodes (N0)
  • No metastasis presence (M0)
  • No previous pelvic radiation therapy
  • Total PSA≤10 ng/ml
  • Gleason score ≤ 6
  • T1-2
  • ≤ 3 positive biopsy at prostatic mapping
  • Signed informed consent

Exclusion Criteria:

  • Positive nodes (N+) or metastatic disease (M+)
  • Inflammatory bowel disease, collagen- vascular disorders or active autoimmune disorders
  • Anticoagulant treatment in progress
  • Hip or pelvic presence of medical devices that could prevent a correct image acquisition
  • Symptomatic haemorrhoidal disease
  • Adverse reactions to iodinate or paramagnetic contrast media
  • Previous malignant cancer, except basocellular skin tumour or other tumours healed since 5 years
  • Previous pelvic radiotherapy
  • Psychiatric disorder that preclude to obtain informed consent

Sites / Locations

  • IRCCS AOU San Martino-IST
  • AO Città della salute e della scienza - Molinette
  • Istituto del Radio "O. Alberti" Spedali Civili - University of Brescia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Stereotactic radiotherapy with a total dose of 36.25 Gy in 5 fractions (7.25 Gy per fraction, 2 fractions per week) in low risk prostate cancer patients is delivered to evaluate acute and subacute toxicty

Outcomes

Primary Outcome Measures

Acute toxicity
during treatment and up to 3 month from RT end
Late toxicity
since 4 month from RT end

Secondary Outcome Measures

Disease free survival
Time from treatment end to biochemical recurrence or loco-regional recurrence or metastatic disease
Disease specific survival
Time from RT end to the date of patient death for cancer
Overall survival
Time from RT end to the date of patient death for any cause

Full Information

First Posted
April 17, 2015
Last Updated
May 10, 2016
Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT02423889
Brief Title
Stereotactic Volumetric Radiotherapy in Prostate Cancer
Official Title
Stereotactic Radiotherapy in Low Risk Prostate Cancer: a Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

4. Oversight

5. Study Description

Brief Summary
This is a prospective, single arm, phase II, multicentric study. It evaluates the acute and late toxicity after stereotactic radiotherapy in low risk prostate cancer patients. All participants receive a total dose of 36.25 Gy in 5 fractions, twice a week, 7.25 Gy per fraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Hypofractionated radiotherapy, SBRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Stereotactic radiotherapy with a total dose of 36.25 Gy in 5 fractions (7.25 Gy per fraction, 2 fractions per week) in low risk prostate cancer patients is delivered to evaluate acute and subacute toxicty
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Primary Outcome Measure Information:
Title
Acute toxicity
Description
during treatment and up to 3 month from RT end
Time Frame
up to 3 months
Title
Late toxicity
Description
since 4 month from RT end
Time Frame
up to 60 months
Secondary Outcome Measure Information:
Title
Disease free survival
Description
Time from treatment end to biochemical recurrence or loco-regional recurrence or metastatic disease
Time Frame
up to 5 year
Title
Disease specific survival
Description
Time from RT end to the date of patient death for cancer
Time Frame
up to 5 years
Title
Overall survival
Description
Time from RT end to the date of patient death for any cause
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histology of prostate adenocarcinoma Age≥ 18 years Life expectancy≥ 10 years Clinical negative nodes (N0) No metastasis presence (M0) No previous pelvic radiation therapy Total PSA≤10 ng/ml Gleason score ≤ 6 T1-2 ≤ 3 positive biopsy at prostatic mapping Signed informed consent Exclusion Criteria: Positive nodes (N+) or metastatic disease (M+) Inflammatory bowel disease, collagen- vascular disorders or active autoimmune disorders Anticoagulant treatment in progress Hip or pelvic presence of medical devices that could prevent a correct image acquisition Symptomatic haemorrhoidal disease Adverse reactions to iodinate or paramagnetic contrast media Previous malignant cancer, except basocellular skin tumour or other tumours healed since 5 years Previous pelvic radiotherapy Psychiatric disorder that preclude to obtain informed consent
Facility Information:
Facility Name
IRCCS AOU San Martino-IST
City
Genoa
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
AO Città della salute e della scienza - Molinette
City
Turin
State/Province
TO
Country
Italy
Facility Name
Istituto del Radio "O. Alberti" Spedali Civili - University of Brescia
City
Brescia
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Volumetric Radiotherapy in Prostate Cancer

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